Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
This recall is currently active, issued June 27, 2018. It was issued by Genicon, Inc..
- Company
- Genicon, Inc.
- Recall Initiated
- June 27, 2018
- Recall Number
- Z-2005-2020
- Quantity
- 1550
- Firm Location
- Winter Park, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
Lot / Code Info
Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
Root Cause
Labeling design
Action Taken
A recall notification letter and updated Instructions for Use (IFU) labeling was sent to consignees on 5/1/2020. The firm is asking that labeling be provided to surgeons for them to read and to familiarize themselves with proper use of the specimen bag for multiple retrievals in the same patient. An Acknowlegement/Receipt Form was provided with response required.